MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA SMALL APPLIER; CLIP, IMPLANTABLE

Model Number MCS20

Device Problems Failure to Form Staple (2579); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "please confirm, did issue result in change of procedure or alteration in post-op patient care? no, it didn't lead to impaired post-op care.It did not involve any change in the procedure, it required a few more minutes to complete the procedure." an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Event Description

It was reported that during a thyroidectomy, although the clips appeared closed, a few minutes later they dislocated from the place of application.This caused blood to leak from the previously clipped and dissected vessel.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15931682
• MDR Text Key: 307894791
• Report Number: 3005075853-2022-08403
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 30705036002493
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCS20
• Device Catalogue Number: MCS20
• Device Lot Number: 930A83
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1